The present invention relates generally to clinical research trials and, more particularly, to a system and method for managing patient events, including appointments. The terms “research subjects” and “patients” are used interchangeably throughout.
The scientific value of clinical research trials significantly depends on the careful management of a large number of people and events to ensure, for example, that specific events occur within specific time ranges (i.e. clinic visits occur within certain time parameters) and that the results from such events (i.e. enrollment, withdrawal or continuation, for example) are properly recorded and monitored. Events may include any occurrence related to the administration of a clinical research trial, such as appointments, and even engendering the goodwill of participants like sending birthday cards or small gifts of appreciation.
The people involved in a clinical research trial can be generally grouped into three classes: administrators, investigators, and participants. Administrators may include the sponsor of the study or management of the clinical research organization who oversee and implement a clinical research trial. Investigators include the independent physicians conducting the research and their employees. One principal responsibility of investigators and administrators is to track and manage the participants in a clinical research trial. Participants may include individuals from the general public who have voluntarily agreed to participate in a clinical research trial and have been screened to verify that they satisfy any necessary criteria for participation.
A single clinical research trial may involve a number of investigators who are each conducting the trial relative to a set of participants. At the same time, the confidentiality requirements of clinical research trials often prevent certain administrators from obtaining personal information of participants, such as the participants' name and contact information, even though the use of such information may be necessary. For this and other reasons, systems and methods known in the art for managing clinical research trials are often expensive and can compromise the success of the clinical research trial through insufficient documenting and recording of events, errors in the dispensing of the clinical trial protocol, and insufficient and untimely communication of the status of the clinical research trial as it is being implemented to allow for corrective adjustments. Therefore, it can be appreciated that there is a need for a system and method for managing patient events for clinical research trials that is inexpensive and will provide a convenient and timely means for monitoring, documenting, recording, and communicating relevant aspects of a clinical research trial for and between administrators, investigators, and participants without compromising confidentiality. The present invention provides these and other advantages, as will be apparent from the following detailed description and accompanying figures.